Manager, SDM China Lead
Core
Manage ICSR case management teams, medical coding, and operational oversight for Safety Data Management (SDM) processes, ensuring compliance with global regulations and quality standards.
Role type
Senior IC manager (Safety Data Management / Pharmacovigilance)
Builds
Production safety data pipelines and compliant ICSR workflows
Domain
Life Sciences / Pharmacovigilance
Required skills
ICSR case management, Medical coding, Pharmacovigilance operations, Regulatory compliance (ICH-GCP, GxP), Team leadership, Performance metrics analysis, Vocabulary governance, Clinical development processes, Safety database management, Change management
Preferred skills
None stated
Technologies
Safety databases, AE data tools, Reporting mechanisms, Clinical and safety systems, Coding platforms
Responsibilities
Manage ICSR intake, triage, entry, and analysis teams; Oversee coding and vocabulary governance; Ensure compliance with SOPs and regulatory requirements; Coach and develop team members; Drive cross-functional alignment and process improvements.
Seniority
Manager, hands-on leadership